Aldeyra Therapeutics (NASDAQ:ALDX) enrolled the first patient in its Phase 3 GUARD trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR).
PVR is an inflammatory disorder of the retina that leads to severe retinal scarring and blindness. There are currently no approved treatments.
ADX-2191 is an intravitreal formulation of methotrexate that has been granted FDA orphan drug and fast track designation for the prevention PVR. It is designed to down-regulate abnormal retinal cell proliferation to reduce retinal scarring.
The trial will evaluate the efficacy of intravitreal injections of ADX-2191 versus the standard-of-care for the prevention of PVR by comparing recurrent retinal detachment rates over a 24-week period following surgical repair.
“Initiation of patient enrollment in the GUARD trial marks an important step toward our goal of improving clinical outcomes for the thousands of patients with this rare but devastating condition,” Dr. Todd Brady, Aldeyra’s president and CEO, said in a statement.
“Today, the only option for patients who develop PVR is surgery, which fails in a significant number of cases. ADX-2191 is a new therapeutic approach with the potential to prevent vision loss from recurrent retinal detachments,” he added.
